Proposal for a Council Decision on the signature, on behalf of the European Community, of the Cartagena Protocol on Biosafety
Date: 2000-03-30
Institutions: European Commission
Subjects: UN convention, biodiversity, biotechnology, environmental protection, protocol to an agreement

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 30.3.2000
COM(2000) 182 final

2000/0072 (ACC)

Proposal for a

COUNCIL DECISION

on the signature, on behalf of the European Community,
of the Cartagena Protocol on Biosafety

(presented by the Commission)

EXPLANATORY MEMORANDUM

On 19 October 19951 the Council authorised the Commission to participate, on behalf of the
Community,
in the negotiations on a Protocol on Biosafety under the Convention on
Biological Diversity. The Community reached in these negotiations all its main objectives as
set out in its negotiation directives, in particular the Council Conclusions of 13 December
19992.

Promoting measures at international level to deal with regional or worldwide environmental
problems is one of the objectives of the Community’s policy on the environment,
in
accordance with Article 174 of the Treaty, which includes the conservation and sustainable
use of biological diversity.

The main focus of the Cartagena Protocol on Biosafety is the intentional transboundary
movements of living modified organisms and it affects therefore international trade. The
Decision to sign should therefore be based on article 133 and 174(4), in conjunction with the
first sentence of the first subparagraph of art. 300 (2).

By decision 93/626/EEC3, the Community concluded the Convention on Biological Diversity
under the auspices of the United Nations Environment Programme. Pursuant to Article 19 (3)
of the Convention, the second Conference of the Parties to the Convention established in
19954 a negotiation process to consider the need for and modalities of a protocol on biosafety.

The Cartagena Protocol on Biosafety provides a framework, based on the precautionary
principle, for the safe transfer, handling and use of living modified organisms resulting from
modern biotechnology that may have adverse effects on the conservation and sustainable use
taking also into account risks to human health and specifically
of biological diversity,
focussing on transboundary movements.

The Cartagena Protocol on Biosafety was adopted by consensus in Montreal on 29 January
2000 during the Extraordinary Conference of the Parties to the Convention on Biological
Diversity.

The Protocol will be open for signature in Nairobi during the fifth meeting of the Conference
of the Parties to the Convention in Nairobi from 15 to 26 May 2000, and at the UN
Headquarters in New York from 5 June 2000 to 4 June 2001.

The Commission considers that by signing the Cartagena Protocol on Biosafety in Nairobi in
May, the European Community would give an important political signal to all parties that
signature and ratification of the Protocol should be an absolute priority.

Community competence is preponderant. Linked with the principle of unity in the
international representation of the Community this militates in favour of simultaneous
signature and eventual deposit of the respective instruments of ratification or approval by the
Community and its Member States. In any case, Member States should not sign the Protocol,

1 Council Document 10887/95 ENV 265.
2 Council Document 13799/99 ENV 428.
3 OJ L 309, 13.12.1993, p. 1-20.
4 Consideration of the need for and modalities of a protocol for the safe transfer, handling and use of living
modified organisms, Decision II/5 of the second Conference of the Parties to the Convention on Biological
Diversity.

2

nor eventually deposit their instruments of ratification or approval before the Community
does.

The Commission therefore requests the Council to authorise the President to designate the
persons empowered to sign the Cartagena Protocol on Biosafety on behalf of the Community
and to confer on them the necessary powers.

Considering the above, the Community intends to sign the Cartagena Protocol on Biosafety at
the fifth meeting of the Conference of the Parties to the Convention on Biological Diversity in
Nairobi in May 2000.

3

2000/0072 (ACC)

Proposal for a

COUNCIL DECISION

on the signature, on behalf of the European Community,
of the Cartagena Protocol on Biosafety

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular articles
133 and 174 (4), in conjunction with the first sentence of the first subparagraph of art. 300 (2)
thereof,

Having regard to the proposal from the Commission5,

Whereas:

(1)

(2)

(3)

(4)

(5)

(6)

promoting measures at
to deal with regional or worldwide
level
environmental problems is one of the objectives of the Community’s policy on the
environment,
in accordance with Article 174 of the Treaty, which includes the
conservation and sustainable use of biological diversity;

international

by decision 93/626/EEC6, the Community concluded the Convention on Biological
Diversity under the auspices of the United Nations Environment Programme;

the Commission, which was authorised in 19957 to negotiate on behalf of the
Community, and the Member States, participated in the negotiations for a Protocol on
Biosafety as stipulated in Article 19 (3) of the Convention on Biological Diversity;

the Cartagena Protocol on Biosafety was adopted in Montreal on 29 January 2000;

the Protocol provides a framework, based on the precautionary principle, for the safe
transfer, handling and use of living modified organisms resulting from modern
biotechnology that may have adverse effects on the conservation and sustainable use
of biological diversity, taking also into account risks to human health and specifically
focussing on transboundary movements;

the Protocol, pursuant to Article 36 thereof, shall be open for signature by States and
regional economic integration organisations at the 5th Conference of the Parties to the
Convention on Biological Diversity in Nairobi from 15 to 26 May 2000, and at United
Nations Headquarters in New York from 5 June 2000 to 4 June 2001;

5 OJ C , , p. .
6 OJ L 309, 13.12.1993, p. 1-20.
7 Council Document 10887/95 ENV 265.

4

(7)

(8)

preponderant Community competence linked with the principle of unity in the
international representation of the Community militate in favour of simultaneous
signature and eventual deposit of the respective instruments of ratification or approval
by the Community and its Member States, and prevent Member States to sign the
instruments of ratification or approval before the
Protocol or eventually deposit
Community does;

it is therefore convenient that the Cartagena Protocol on Biosafety be signed on behalf
of the Community during the 5th Conference of the Parties to the Convention on
Biological Diversity, subject to subsequent conclusion;

HAS DECIDED AS FOLLOWS:

Sole Article

is hereby authorised to designate the person or persons
The President of the Council
empowered to sign, on behalf of the Community, subject to subsequent conclusion, the
Cartagena Protocol on Biosafety, and to confer upon them the powers necessary for that
purpose.

Done at,

For the Council
The President

5

CARTAGENA PROTOCOL ON BIOSAFETY
to the convention on biological diversity

The Parties to this Protocol,

Being Parties to the Convention on Biological Diversity, hereinafter referred to as "the
Convention",

Recalling Article 19, paragraphs 3 and 4, and Articles 8 (g) and 17 of the Convention,

Recalling also decision II/5 of 17 November 1995 of the Conference of the Parties to the
Convention to develop a Protocol on biosafety, specifically focusing on transboundary
movement of any living modified organism resulting from modern biotechnology that may
have adverse effect on the conservation and sustainable use of biological diversity, setting out
for consideration, in particular, appropriate procedures for advance informed agreement,

Reaffirming the precautionary approach contained in Principle 15 of the Rio Declaration on
Environment and Development,

Aware of the rapid expansion of modern biotechnology and the growing public concern over
its potential adverse effects on biological diversity, taking also into account risks to human
health,

Recognizing that modern biotechnology has great potential
developed and used with adequate safety measures for the environment and human health,

for human well-being if

Recognizing also the crucial importance to humankind of centres of origin and centres of
genetic diversity,

Taking into account
the limited capabilities of many countries, particularly developing
countries, to cope with the nature and scale of known and potential risks associated with
living modified organisms,

Recognizing that trade and environment agreements should be mutually supportive with a
view to achieving sustainable development,

Emphasizing that this Protocol shall not be interpreted as implying a change in the rights and
obligations of a Party under any existing international agreements,

Understanding that the above recital is not intended to subordinate this Protocol to other
international agreements,

Have agreed as follows:

1.

ARTICLE 1

OBJECTIVE

ANNEX

In accordance with the precautionary approach contained in Principle 15 of the Rio
Declaration on Environment and Development, the objective of this Protocol is to

6

contribute to ensuring an adequate level of protection in the field of the safe transfer,
handling and use of living modified organisms resulting from modern biotechnology
that may have adverse effects on the conservation and sustainable use of biological
diversity, taking also into account risks to human health, and specifically focusing on
transboundary movements.

2.

ARTICLE 2

GENERAL PROVISIONS

1.

2.

3.

4.

5.

Each Party shall take necessary and appropriate legal, administrative and other
measures to implement its obligations under this Protocol.

The Parties shall ensure that the development, handling, transport, use, transfer
and release of any living modified organisms are undertaken in a manner that
prevents or reduces the risks to biological diversity, taking also into account
risks to human health.

Nothing in this Protocol shall affect in any way the sovereignty of States over
their territorial sea established in accordance with international law, and the
sovereign rights and the jurisdiction which States have in their exclusive
economic zones and their continental shelves in accordance with international
law, and the exercise by ships and aircraft of all States of navigational rights
and freedoms as provided for in international law and as reflected in relevant
international instruments.

Nothing in this Protocol shall be interpreted as restricting the right of a Party to
take action that is more protective of the conservation and sustainable use of
biological diversity than that called for in this Protocol, provided that such
action is consistent with the objective and the provisions of this Protocol and is
in accordance with that Party's other obligations under international law.

The Parties are encouraged to take into account, as appropriate, available
instruments and work undertaken in international forums with
expertise,
competence in the area of risks to human health.

3.

ARTICLE 3

USE OF TERMS

For the purposes of this Protocol:

(a)

(b)

"Conference of the Parties" means the Conference of the Parties to the
Convention;

"Contained use" means any operation, undertaken within a facility, installation
or other physical structure, which involves living modified organisms that are
controlled by specific measures that effectively limit their contact with, and
their impact on, the external environment;

7

(c)

(d)

(e)

(f)

(g)

"Export" means intentional transboundary movement from one Party to another
Party;

"Exporter" means any legal or natural person, under the jurisdiction of the
Party of export, who arranges for a living modified organism to be exported;

"Import" means intentional transboundary movement
another Party;

into one Party from

"Importer" means any legal or natural person, under the jurisdiction of the
Party of import, who arranges for a living modified organism to be imported;

"Living modified organism" means any living organism that possesses a novel
combination of genetic material obtained through the use of modern
biotechnology;

(h)

"Living organism" means any biological entity capable of transferring or
replicating genetic material, including sterile organisms, viruses and viroids;

(i)

"Modern biotechnology" means the application of:

a.

In vitro nucleic acid techniques, including recombinant deoxyribonucleic
acid (DNA) and direct injection of nucleic acid into cells or organelles, or

b.

Fusion of cells beyond the taxonomic family,

that overcome natural physiological
recombination
barriers and that are not techniques used in traditional breeding and
selection.

reproductive or

(j)

(k)

economic

integration organization" means

"Regional
an organization
constituted by sovereign States of a given region, to which its member States
have transferred competence in respect of matters governed by this Protocol
and which has been duly authorized, in accordance with its internal procedures,
to sign, ratify, accept, approve or accede to it;

"Transboundary movement" means the movement of a living modified
organism from one Party to another Party, save that for the purposes of Articles
17 and 24 transboundary movement extends to movement between Parties and
non-Parties.

4.

ARTICLE 4

SCOPE

This Protocol shall apply to the transboundary movement, transit, handling and use
of all living modified organisms that may have adverse effects on the conservation
and sustainable use of biological diversity, taking also into account risks to human
health.

8

5.

ARTICLE 5

PHARMACEUTICALS

Notwithstanding Article 4 and without prejudice to any right of a Party to subject all
living modified organisms to risk assessment prior to the making of decisions on
import, this Protocol shall not apply to the transboundary movement of living
modified organisms which are pharmaceuticals for humans that are addressed by
other relevant international agreements or organisations.

6.

ARTICLE 6

TRANSIT AND CONTAINED USE

1.

2.

Notwithstanding Article 4 and without prejudice to any right of a Party of
to regulate the transport of living modified organisms through its
transit
territory and make available to the Biosafety Clearing-House, any decision of
that Party, subject to Article 2, paragraph 3, regarding the transit through its
territory of a specific living modified organism, the provisions of this Protocol
with respect to the advance informed agreement procedure shall not apply to
living modified organisms in transit.

Notwithstanding Article 4 and without prejudice to any right of a Party to
subject all living modified organisms to risk assessment prior to decisions on
import and to set standards for contained use within its jurisdiction,
the
provisions of this Protocol with respect to the advance informed agreement
procedure shall not apply to the transboundary movement of living modified
organisms destined for contained use undertaken in accordance with the
standards of the Party of import.

7.

ARTICLE 7

APPLICATION OF
PROCEDURE

THE ADVANCE

INFORMED AGREEMENT

1.

2.

3.

4.

Subject to Articles 5 and 6, the advance informed agreement procedure in
Articles 8 to 10 and 12 shall apply prior to the first intentional transboundary
movement of living modified organisms for intentional introduction into the
environment of the Party of import.

"Intentional introduction into the environment" in paragraph 1 above, does not
refer to living modified organisms intended for direct use as food or feed, or
for processing.

Article 11 shall apply prior to the first transboundary movement of living
modified organisms intended for direct use as food or feed, or for processing.

The advance informed agreement procedure shall not apply to the intentional
transboundary movement of living modified organisms identified in a decision
of the Conference of the Parties serving as the meeting of the Parties to this
Protocol as being not likely to have adverse effects on the conservation and

9

sustainable use of biological diversity, taking also into account risks to human
health.

8.

ARTICLE 8

NOTIFICATION

1.

2.

The Party of export shall notify, or require the exporter to ensure notification
to, in writing, the competent national authority of the Party of import prior to
the intentional transboundary movement of a living modified organism that
falls within the scope of Article 7, paragraph 1. The notification shall contain,
at a minimum, the information specified in Annex I.

The Party of export shall ensure that there is a legal requirement for the
accuracy of information provided by the exporter.

9.

ARTICLE 9

ACKNOWLEDGEMENT OF RECEIPT OF NOTIFICATION

1.

The Party of import shall acknowledge receipt of the notification, in writing, to
the notifier within ninety days of its receipt.

2.

The acknowledgement shall state:

(a)

The date of receipt of the notification;

(b) Whether the notification, prima facie, contains the information referred to

in Article 8;

(c) Whether to proceed according to the domestic regulatory framework of

the Party of import or according to the procedure specified in Article 10.

3.

4.

The domestic regulatory framework referred to in paragraph 2 (c) above, shall
be consistent with this Protocol.

A failure by the Party of import to acknowledge receipt of a notification shall
not imply its consent to an intentional transboundary movement.

10.

ARTICLE 10

DECISION PROCEDURE

1.

2.

Decisions taken by the Party of import shall be in accordance with Article 15.

The Party of import shall, within the period of time referred to in Article 9,
inform the notifier,
transboundary
movement may proceed:

in writing, whether

the intentional

(a) Only after the Party of import has given its written consent; or

10

(b) After no less than ninety days without a subsequent written consent.

3. Within two hundred and seventy days of the date of receipt of notification, the
Party of import shall communicate, in writing, to the notifier and to the
Biosafety Clearing-House the decision referred to in paragraph 2 (a) above:

(a) Approving the import, with or without conditions, including how the
decision will apply to subsequent imports of the same living modified
organism;

(b)

Prohibiting the import;

(c) Requesting additional

relevant

information in accordance with its
domestic regulatory framework or Annex I; in calculating the time within
which the Party of import is to respond, the number of days it has to wait
for additional relevant information shall not be taken into account; or

(d)

Informing the notifier that
extended by a defined period of time.

the period specified in this paragraph is

Except in a case in which consent is unconditional, a decision under paragraph
3 above, shall set out the reasons on which it is based.

A failure by the Party of import to communicate its decision within two
hundred and seventy days of the date of receipt of the notification shall not
imply its consent to an intentional transboundary movement.

Lack of scientific certainty due to insufficient relevant scientific information
and knowledge regarding the extent of the potential adverse effects of a living
modified organism on the conservation and sustainable use of biological
diversity in the Party of import, taking also into account risks to human health,
shall not prevent that Party from taking a decision, as appropriate, with regard
to the import of the living modified organism in question as referred to in
paragraph 3 above,
in order to avoid or minimize such potential adverse
effects.

The Conference of the Parties serving as the meeting of the Parties shall, at its
first meeting, decide upon appropriate procedures and mechanisms to facilitate
decision-making by Parties of import.

4.

5.

6.

7.

11.

ARTICLE 11

PROCEDURE FOR LIVING MODIFED ORGANISMS INTENDED FOR
DIRECT USE AS FOOD OR FEED, OR FOR PROCESSING

1.

A Party that makes a final decision regarding domestic use, including placing
on the market, of a living modified organism that may be subject
to
transboundary movement for direct use as food or feed, or for processing shall,
within fifteen days of making that decision, inform the Parties through the
Biosafety Clearing-House. This information shall contain, at a minimum, the
information specified in Annex II. The Party shall provide a copy of the
information, in writing, to the national focal point of each Party that informs

11

in advance that

the Secretariat
it does not have access to the Biosafety
Clearing-House. This provision shall not apply to decisions regarding field
trials.

The Party making a decision under paragraph 1 above, shall ensure that there is
a legal requirement for the accuracy of information provided by the applicant.

Any Party may request additional information from the authority identified in
paragraph (b) of Annex II.

A Party may take a decision on the import of living modified organisms
intended for direct use as food or feed, or for processing, under its domestic
regulatory framework that is consistent with the objective of this Protocol.

Each Party shall make available to the Biosafety Clearing-House copies of any
national laws, regulations and guidelines applicable to the import of living
modified organisms intended for direct use as food or feed, or for processing, if
available.

A developing country Party or a Party with an economy in transition may, in
the absence of the domestic regulatory framework referred to in paragraph 4
above, and in exercise of its domestic jurisdiction, declare through the
Biosafety Clearing-House that its decision prior to the first import of a living
modified organism intended for direct use as food or feed, or for processing, on
which information has been provided under paragraph 1 above, will be taken
according to the following:

(a) A risk assessment undertaken in accordance with Article 15; and

(b) A decision made within a predictable timeframe, not exceeding two

hundred and seventy days.

Failure by a Party to communicate its decision according to paragraph 6 above,
shall not imply its consent or refusal to the import of a living modified
organism intended for direct use as food or feed, or for processing, unless
otherwise specified by the Party.

Lack of scientific certainty due to insufficient relevant scientific information
and knowledge regarding the extent of the potential adverse effects of a living
modified organism on the conservation and sustainable use of biological
diversity in the Party of import, taking also into account risks to human health,
shall not prevent that Party from taking a decision, as appropriate, with regard
to the import of that living modified organism intended for direct use as food or
feed, or for processing, in order to avoid or minimize such potential adverse
effects.

A Party may indicate its needs for financial and technical assistance and
capacity-building with respect to living modified organisms intended for direct
use as food or feed, or for processing. Parties shall cooperate to meet these
needs in accordance with Articles 22 and 28.

2.

3.

4.

5.

6.

7.

8.

9.

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12.

ARTICLE 12

REVIEW OF DECISIONS

1.

2.

3.

4.

A Party of import may, at any time, in light of new scientific information on
potential adverse effects on the conservation and sustainable use of biological
diversity, taking also into account the risks to human health, review and change
a decision regarding an intentional transboundary movement. In such case, the
Party shall, within thirty days, inform any notifier that has previously notified
movements of the living modified organism referred to in such decision, as
well as the Biosafety Clearing-House, and shall set out the reasons for its
decision.

A Party of export or a notifier may request the Party of import to review a
decision it has made in respect of it under Article 10 where the Party of export
or the notifier considers that:

(a) A change in circumstances has occurred that may influence the outcome

of the risk assessment upon which the decision was based; or

(b) Additional relevant scientific or

technical

information has become

available.

The Party of import shall respond to such a request within ninety days and set
out the reasons for its decision.

The Party of import may, at
subsequent imports.

its discretion, require a risk assessment for

13.

ARTICLE 13

SIMPLIFIED PROCEDURE

1.

A Party of import may, provided that adequate measures are applied to ensure
the safe intentional transboundary movement of living modified organisms in
accordance with the objective of this Protocol, specify in advance to the
Biosafety Clearing-House:

(a) Cases in which intentional transboundary movement to it may take place

at the same time as the movement is notified to the Party of import; and

(b)

Imports of living modified organisms to it to be exempted from the
advance informed agreement procedure.

Notifications under subparagraph (a) above, may apply to subsequent
similar movements to the same Party.

2.

The information relating to an intentional transboundary movement that is to
be provided in the notifications referred to in paragraph 1 (a) above shall be the
information specified in Annex I.

13

14.

ARTICLE 14

BILATERAL, REGIONAL AND MULTILATERAL AGREEMENTS AND
ARRANGEMENTS

1.

2.

3.

4.

regarding intentional

Parties may enter into bilateral, regional and multilateral agreements and
arrangements
living
modified organisms, consistent with the objective of this Protocol and provided
in a lower level of
that such agreements and arrangements do not result
protection than that provided for by the Protocol.

transboundary movements of

The Parties shall inform each other, through the Biosafety Clearing-House, of
any such bilateral, regional and multilateral agreements and arrangements that
they have entered into before or after the date of entry into force of this
Protocol.

transboundary
The provisions of this Protocol shall not affect
movements that take place pursuant to such agreements and arrangements as
between the parties to those agreements or arrangements.

intentional

Any Party may determine that its domestic regulations shall apply with respect
to specific imports to it and shall notify the Biosafety Clearing-House of its
decision.

15.

ARTICLE 15

RISK ASSESSMENT

1.

2.

3.

Risk assessments undertaken pursuant to this Protocol shall be carried out in a
scientifically sound manner, in accordance with Annex III and taking into
account recognized risk assessment techniques. Such risk assessments shall be
based, at a minimum, on information provided in accordance with Article 8 and
other available scientific evidence in order to identify and evaluate the possible
adverse effects of
living modified organisms on the conservation and
sustainable use of biological diversity, taking also into account risks to human
health.

The Party of import shall ensure that risk assessments are carried out for
decisions taken under Article 10. It may require the exporter to carry out the
risk assessment.

The cost of risk assessment shall be borne by the notifier if the Party of import
so requires.

16.

ARTICLE 16

RISK MANAGEMENT

1.

The Parties shall, taking into account Article 8 (g) of the Convention, establish
and maintain appropriate mechanisms, measures and strategies to regulate,
manage and control risks identified in the risk assessment provisions of this

14

Protocol associated with the use, handling and transboundary movement of
living modified organisms.

2. Measures based on risk assessment shall be imposed to the extent necessary to
prevent adverse effects of the living modified organism on the conservation
and sustainable use of biological diversity, taking also into account risks to
human health, within the territory of the Party of import.

3.

take appropriate measures

to prevent unintentional
Each Party shall
transboundary movements of
including such
measures as requiring risk assessments to be carried out prior to the first
release of a living modified organism.

living modified organisms,

4. Without prejudice to paragraph 2 above, each Party shall endeavour to ensure
that any living modified organism, whether imported or locally developed, has
undergone an appropriate period of observation that is commensurate with its
life-cycle or generation time before it is put to its intended use.

5.

Parties shall cooperate with a view to:

(a)

Identifying living modified organisms or specific traits of living modified
organisms that may have adverse effects on the conservation and
sustainable use of biological diversity, taking also into account risks to
human health; and

(b)

Taking appropriate measures regarding the treatment of such living
modified organisms or specific traits.

17.

ARTICLE 17

UNINTENTIONAL TRANSBOUNDARY MOVEMENTS AND EMERGENCY
MEASURES

1.

2.

Each Party shall take appropriate measures to notify affected or potentially
affected States, the Biosafety Clearing-House and, where appropriate, relevant
international organizations, when it knows of an occurrence under
its
jurisdiction resulting in a release that leads, or may lead, to an unintentional
transboundary movement of a living modified organism that is likely to have
significant adverse effects on the conservation and sustainable use of biological
diversity, taking also into account risks to human health in such States. The
notification shall be provided as soon as the Party knows of the above situation.

Each Party shall, no later than the date of entry into force of this Protocol for it,
make available to the Biosafety Clearing-House the relevant details setting out
its point of contact for the purposes of receiving notifications under this
Article.

3.

Any notification arising from paragraph l above, should include:

(a) Available relevant information on the estimated quantities and relevant

characteristics and/or traits of the living modified organism;

15

(b)

Information on the circumstances and estimated date of the release, and
on the use of the living modified organism in the originating Party;

(c) Any available information about the possible adverse effects on the
conservation and sustainable use of biological diversity, taking also into
account risks to human health, as well as available information about
possible risk management measures;

(d) Any other relevant information; and

(e) A point of contact for further information.

4.

In order to minimize any significant adverse effects on the conservation and
sustainable use of biological diversity, taking also into account risks to human
health, each Party, under whose jurisdiction the release of the living modified
organism referred to in paragraph l above, occurs, shall immediately consult
the affected or potentially affected States to enable them to determine
appropriate responses and initiate necessary action,
including emergency
measures.

18.

ARTICLE 18

HANDLING, TRANSPORT, PACKAGING AND IDENTIFICATION

1.

In order to avoid adverse effects on the conservation and sustainable use of
biological diversity, taking also into account risks to human health, each Party
shall take necessary measures to require that living modified organisms that are
subject
transboundary movement within the scope of this
Protocol are handled, packaged and transported under conditions of safety,
taking into consideration relevant international rules and standards.

to intentional

2.

Each Party shall take measures to require that documentation accompanying:

(a)

(b)

Living modified organisms that are intended for direct use as food or
feed, or for processing, clearly identifies that they "may contain" living
modified organisms and are not intended for intentional introduction into
the environment, as well as a contact point for further information. The
Conference of the Parties serving as the meeting of the Parties to this
Protocol shall take a decision on the detailed requirements for this
purpose,
identity and any unique
identification, no later than two years after the date of entry into force of
this Protocol;

including specification of

their

Living modified organisms that are destined for contained use clearly
identifies them as
living modified organisms; and specifies any
requirements for the safe handling, storage, transport and use, the contact
point for further information, including the name and address of the
individual and institution to whom the living modified organisms are
consigned; and

(c)

Living modified organisms that are intended for intentional introduction
into the environment of the Party of import and any other living modified

16

organisms within the scope of the Protocol, clearly identifies them as
traits
living modified organisms; specifies the identity and relevant
and/or characteristics, any requirements for the safe handling, storage,
transport and use,
the contact point for further information and, as
appropriate, the name and address of the importer and exporter; and
contains a declaration that
is in conformity with the
the movement
requirements of this Protocol applicable to the exporter.

3.

The Conference of the Parties serving as the meeting of the Parties to this
Protocol shall consider the need for and modalities of developing standards
with regard to identification, handling, packaging and transport practices, in
consultation with other relevant international bodies.

19.

ARTICLE 19

COMPETENT NATIONAL AUTHORITIES AND NATIONAL FOCAL
POINTS

1.

2.

Each Party shall designate one national focal point to be responsible on its
behalf for liaison with the Secretariat. Each Party shall also designate one or
more competent national authorities, which shall be responsible for performing
the administrative functions required by this Protocol and which shall be
authorized to act on its behalf with respect to those functions. A Party may
designate a single entity to fulfill
the functions of both focal point and
competent national authority.

Each Party shall, no later than the date of entry into force of this Protocol for it,
notify the Secretariat of the names and addresses of its focal point and its
competent national authority or authorities. Where a Party designates more
than one competent national authority, it shall convey to the Secretariat, with
its notification thereof, relevant information on the respective responsibilities
of those authorities. Where applicable, such information shall, at a minimum,
specify which competent authority is responsible for which type of living
modified organism. Each Party shall forthwith notify the Secretariat of any
changes in the designation of its national focal point or in the name and address
or responsibilities of its competent national authority or authorities.

3.

The Secretariat shall forthwith inform the Parties of the notifications it receives
under paragraph 2 above, and shall also make such information available
through the Biosafety Clearing-House.

20.

ARTICLE 20

INFORMATION SHARING AND THE BIOSAFETY CLEARING-HOUSE

1.

A Biosafety Clearing-House is hereby established as part of the clearing-house
mechanism under Article 18, paragraph 3, of the Convention, in order to:

(a)

Facilitate the exchange of scientific, technical, environmental and legal
information on, and experience with, living modified organisms; and

17

(b) Assist Parties to implement the Protocol, taking into account the special
needs of developing country Parties, in particular the least developed and
small
island developing States among them, and countries with
economies in transition as well as countries that are centres of origin and
centres of genetic diversity.

2.

The Biosafety Clearing-House shall serve as a means through which
information is made available for the purposes of paragraph 1 above. It shall
provide access to information made available by the Parties relevant to the
implementation of the Protocol. It shall also provide access, where possible, to
other international biosafety information exchange mechanisms.

3. Without prejudice to the protection of confidential information, each Party
shall make available to the Biosafety Clearing-House any information required
to be made available to the Biosafety Clearing-House under this Protocol, and:

(a) Any existing laws, regulations and guidelines for implementation of the
Protocol, as well as information required by the Parties for the advance
informed agreement procedure;

(b) Any bilateral, regional and multilateral agreements and arrangements;

(c)

Summaries of its risk assessments or environmental reviews of living
modified organisms generated by its regulatory process, and carried out
in accordance with Article 15, including, where appropriate, relevant
information regarding products thereof, namely, processed materials that
are of living modified organism origin, containing detectable novel
combinations of replicable genetic material obtained through the use of
modern biotechnology;

(d)

Its final decisions regarding the importation or release of living modified
organisms; and

(e) Reports submitted by it pursuant

to Article 33,

including those on

implementation of the advance informed agreement procedure.

4.

The modalities of the operation of the Biosafety Clearing-House, including
reports on its activities, shall be considered and decided upon by the
Conference of the Parties serving as the meeting of the Parties to this Protocol
at its first meeting, and kept under review thereafter.

21.

ARTICLE 21

CONFIDENTIAL INFORMATION

1.

2.

The Party of import shall permit the notifier to identify information submitted
under the procedures of this Protocol or required by the Party of import as part
of the advance informed agreement procedure of the Protocol that is to be
treated as confidential. Justification shall be given in such cases upon request.

The Party of import shall consult the notifier if it decides that information
identified by the notifier as confidential does not qualify for such treatment and

18

shall, prior to any disclosure, inform the notifier of its decision, providing
reasons on request, as well as an opportunity for consultation and for an
internal review of the decision prior to disclosure.

Each Party shall protect confidential information received under this Protocol,
including any confidential information received in the context of the advance
informed agreement procedure of the Protocol. Each Party shall ensure that it
has procedures to protect such information and shall protect the confidentiality
of such information in a manner no less favourable than its treatment of
confidential
information in connection with domestically produced living
modified organisms.

The Party of import shall not use such information for a commercial purpose,
except with the written consent of the notifier.

If a notifier withdraws or has withdrawn a notification, the Party of import
the confidentiality of commercial and industrial information,
shall respect
including research and development information as well as information on
which the Party and the notifier disagree as to its confidentiality.

3.

4.

5.

6. Without prejudice to paragraph 5 above, the following information shall not be

considered confidential:

(a)

The name and address of the notifier;

(b) A general description of the living modified organism or organisms;

(c) A summary of the risk assessment of the effects on the conservation and
sustainable use of biological diversity, taking also into account risks to
human health; and

(d) Any methods and plans for emergency response.

22.

ARTICLE 22

CAPACITY-BUILDING

1.

2.

The Parties shall cooperate in the development and/or strengthening of human
resources and institutional capacities in biosafety, including biotechnology to
the extent that it is required for biosafety, for the purpose of the effective
implementation of this Protocol, in developing country Parties, in particular the
least developed and small island developing States among them, and in Parties
with economies in transition,
including through existing global, regional,
subregional and national institutions and organizations and, as appropriate,
through facilitating private sector involvement.

the purposes of

implementing paragraph 1 above,

For
in relation to
cooperation, the needs of developing country Parties, in particular the least
developed and small
island developing States among them, for financial
technology and know-how in
resources and access to and transfer of
accordance with the relevant provisions of the Convention, shall be taken fully
into account for capacity-building in biosafety. Cooperation in capacity-

19

building shall, subject to the different situation, capabilities and requirements
of each Party, include scientific and technical training in the proper and safe
management of biotechnology, and in the use of risk assessment and risk
management
technological and
institutional capacities in biosafety. The needs of Parties with economies in
transition shall also be taken fully into account for such capacity-building in
biosafety.

for biosafety, and the enhancement of

23.

ARTICLE 23

PUBLIC AWARENESS AND PARTICIPATION

1. The Parties shall:

(a)

Promote and facilitate public awareness, education and participation
living modified
concerning the safe transfer, handling and use of
organisms in relation to the conservation and sustainable use of
biological diversity, taking also into account risks to human health. In
doing so, the Parties shall cooperate, as appropriate, with other States and
international bodies;

(b)

Endeavour to ensure that public awareness and education encompass
access to information on living modified organisms identified in
accordance with this Protocol that may be imported.

2

3.

The Parties shall, in accordance with their respective laws and regulations,
consult the public in the decision-making process regarding living modified
organisms and shall make the results of such decisions available to the public,
while respecting confidential information in accordance with Article 21.

Each Party shall endeavour to inform its public about the means of public
access to the Biosafety Clearing-House.

24.

ARTICLE 24

NON-PARTIES

1.

2.

Transboundary movements of living modified organisms between Parties and
non-Parties shall be consistent with the objective of this Protocol. The Parties
may enter into bilateral, regional and multilateral agreements and arrangements
with non-Parties regarding such transboundary movements.

The Parties shall encourage non-Parties to adhere to this Protocol and to
contribute appropriate information to the Biosafety Clearing-House on living
modified organisms released in, or moved into or out of, areas within their
national jurisdictions.

20

25.

ARTICLE 25

ILLEGAL TRANSBOUNDARY MOVEMENTS

1.

2.

3.

Each Party shall adopt appropriate domestic measures aimed at preventing and,
living modified
if appropriate, penalizing transboundary movements of
organisms carried out in contravention of its domestic measures to implement
this Protocol. Such movements shall be deemed illegal
transboundary
movements.

In the case of an illegal transboundary movement, the affected Party may
request the Party of origin to dispose, at its own expense, of the living modified
organism in question by repatriation or destruction, as appropriate.

Each Party shall make available to the Biosafety Clearing-House information
concerning cases of illegal transboundary movements pertaining to it.

26.

ARTICLE 26

SOCIO-ECONOMIC CONSIDERATIONS

1.

2.

The Parties, in reaching a decision on import under this Protocol or under its
domestic measures implementing the Protocol, may take into account,
consistent with their international obligations, socio-economic considerations
arising from the impact of living modified organisms on the conservation and
sustainable use of biological diversity, especially with regard to the value of
biological diversity to indigenous and local communities.

The Parties are encouraged to cooperate on research and information exchange
on any socio-economic impacts of living modified organisms, especially on
indigenous and local communities.

27.

ARTICLE 27

LIABILITY AND REDRESS

The Conference of the Parties serving as the meeting of the Parties to this Protocol
shall, at its first meeting, adopt a process with respect to the appropriate elaboration
of international rules and procedures in the field of liability and redress for damage
resulting from transboundary movements of living modified organisms, analysing
and taking due account of the ongoing processes in international law on these
matters, and shall endeavour to complete this process within four years.

28.

ARTICLE 28

FINANCIAL MECHANISM AND RESOURCES

1.

In considering financial resources for the implementation of this Protocol, the
Parties shall take into account the provisions of Article 20 of the Convention.

21

2.

3.

4.

5.

6.

The financial mechanism established in Article 21 of the Convention shall,
through the institutional structure entrusted with its operation, be the financial
mechanism for this Protocol.

Regarding the capacity-building referred to in Article 22 of this Protocol, the
Conference of the Parties serving as the meeting of the Parties to this Protocol,
in providing guidance with respect to the financial mechanism referred to in
paragraph 2 above, for consideration by the Conference of the Parties, shall
the need for financial resources by developing country
take into account
Parties, in particular the least developed and the small island developing States
among them.

In the context of paragraph 1 above, the Parties shall also take into account the
needs of the developing country Parties, in particular the least developed and
island developing States among them, and of the Parties with
the small
their
economies in transition,
capacity-building requirements for the purposes of the implementation of this
Protocol.

in their efforts to identify and implement

The guidance to the financial mechanism of the Convention in relevant
decisions of the Conference of the Parties, including those agreed before the
adoption of this Protocol, shall apply, mutatis mutandis, to the provisions of
this Article.

The developed country Parties may also provide, and the developing country
Parties and the Parties with economies in transition avail themselves of,
financial and technological resources for the implementation of the provisions
of this Protocol through bilateral, regional and multilateral channels.

29.

ARTICLE 29

CONFERENCE OF THE PARTIES SERVING AS THE MEETING OF THE
PARTIES TO THIS PROTOCOL

1.

2.

The Conference of the Parties shall serve as the meeting of the Parties to this
Protocol.

Parties to the Convention that are not Parties to this Protocol may participate as
observers in the proceedings of any meeting of the Conference of the Parties
serving as the meeting of the Parties to this Protocol. When the Conference of
the Parties serves as the meeting of the Parties to this Protocol, decisions under
this Protocol shall be taken only by those that are Parties to it.

3. When the Conference of the Parties serves as the meeting of the Parties to this
Protocol, any member of the bureau of the Conference of the Parties
representing a Party to the Convention but, at that time, not a Party to this
Protocol, shall be substituted by a member to be elected by and from among
the Parties to this Protocol.

4.

The Conference of the Parties serving as the meeting of the Parties to this
Protocol shall keep under regular review the implementation of this Protocol
and shall make, within its mandate, the decisions necessary to promote its

22

effective implementation. It shall perform the functions assigned to it by this
Protocol and shall:

(a) Make recommendations on any matters necessary for the implementation

of this Protocol;

(b)

(c)

Establish such subsidiary bodies as are deemed necessary for
implementation of this Protocol;

the

Seek and utilize, where appropriate, the services and cooperation of, and
information provided by, competent
international organizations and
intergovernmental and non-governmental bodies;

(d) Establish the form and the intervals for transmitting the information to be
submitted in accordance with Article 33 of this Protocol and consider
such information as well as reports submitted by any subsidiary body;

(e) Consider and adopt, as required, amendments to this Protocol and its
annexes, as well as any additional annexes to this Protocol, that are
deemed necessary for the implementation of this Protocol; and

(f)

Exercise such other functions as may be required for the implementation
of this Protocol.

The rules of procedure of the Conference of the Parties and financial rules of
the Convention shall be applied, mutatis mutandis, under this Protocol, except
as may be otherwise decided by consensus by the Conference of the Parties
serving as the meeting of the Parties to this Protocol.

The first meeting of the Conference of the Parties serving as the meeting of the
Parties to this Protocol shall be convened by the Secretariat in conjunction with
the first meeting of the Conference of the Parties that is scheduled after the date
of the entry into force of this Protocol. Subsequent ordinary meetings of the
Conference of the Parties serving as the meeting of the Parties to this Protocol
shall be held in conjunction with ordinary meetings of the Conference of the
Parties, unless otherwise decided by the Conference of the Parties serving as
the meeting of the Parties to this Protocol.

Extraordinary meetings of the Conference of the Parties serving as the meeting
of the Parties to this Protocol shall be held at such other times as may be
deemed necessary by the Conference of the Parties serving as the meeting of
the Parties to this Protocol, or at the written request of any Party, provided that,
within six months of the request being communicated to the Parties by the
Secretariat, it is supported by at least one third of the Parties.

The United Nations, its specialized agencies and the International Atomic
Energy Agency, as well as any State member thereof or observers thereto not
party to the Convention, may be represented as observers at meetings of the
Conference of the Parties serving as the meeting of the Parties to this Protocol.
Any body or agency, whether national or international, governmental or non-
governmental, that is qualified in matters covered by this Protocol and that has
informed the Secretariat of its wish to be represented at a meeting of the
Conference of the Parties serving as a meeting of the Parties to this Protocol as

23

5.

6.

7.

8.

an observer, may be so admitted, unless at least one third of the Parties present
the admission and
object. Except as otherwise provided in this Article,
participation of observers shall be subject to the rules of procedure, as referred
to in paragraph 5 above.

30.

ARTICLE 30

SUBSIDIARY BODIES

1.

2.

Any subsidiary body established by or under the Convention may, upon a
decision by the Conference of the Parties serving as the meeting of the Parties
to this Protocol, serve the Protocol, in which case the meeting of the Parties
shall specify which functions that body shall exercise.

Parties to the Convention that are not Parties to this Protocol may participate as
observers in the proceedings of any meeting of any such subsidiary bodies.
When a subsidiary body of the Convention serves as a subsidiary body to this
Protocol, decisions under the Protocol shall be taken only by the Parties to the
Protocol.

3. When a subsidiary body of the Convention exercises its functions with regard
to matters concerning this Protocol, any member of the bureau of that
subsidiary body representing a Party to the Convention but, at that time, not a
Party to the Protocol, shall be substituted by a member to be elected by and
from among the Parties to the Protocol.

31.

ARTICLE 31

SECRETARIAT

1.

2.

3.

The Secretariat established by Article 24 of the Convention shall serve as the
secretariat to this Protocol.

Article 24, paragraph 1, of the Convention on the functions of the Secretariat
shall apply, mutatis mutandis, to this Protocol.

To the extent that they are distinct, the costs of the secretariat services for this
Protocol shall be met by the Parties hereto. The Conference of the Parties
serving as the meeting of the Parties to this Protocol shall, at its first meeting,
decide on the necessary budgetary arrangements to this end.

32.

ARTICLE 32

RELATIONSHIP WITH THE CONVENTION

Except as otherwise provided in this Protocol, the provisions of the Convention
relating to its protocols shall apply to this Protocol.

24

33.

ARTICLE 33

MONITORING AND REPORTING

Each Party shall monitor the implementation of its obligations under this Protocol,
and shall, at intervals to be determined by the Conference of the Parties serving as
the meeting of the Parties to this Protocol, report to the Conference of the Parties
serving as the meeting of the Parties to this Protocol on measures that it has taken to
implement the Protocol.

34.

ARTICLE 34

COMPLIANCE

The Conference of the Parties serving as the meeting of the Parties to this Protocol
its first meeting, consider and approve cooperative procedures and
shall, at
institutional mechanisms to promote compliance with the provisions of this Protocol
and to address cases of non-compliance. These procedures and mechanisms shall
include provisions to offer advice or assistance, where appropriate. They shall be
separate from, and without prejudice to, the dispute settlement procedures and
mechanisms established by Article 27 of the Convention.

35.

ARTICLE 35

ASSESSMENT AND REVIEW

The Conference of the Parties serving as the meeting of the Parties to this Protocol
shall undertake, five years after the entry into force of this Protocol and at least every
five years thereafter, an evaluation of the effectiveness of the Protocol, including an
assessment of its procedures and annexes.

36.

ARTICLE 36

SIGNATURE

This Protocol shall be open for signature at the United Nations Office at Nairobi by
States and regional economic integration organizations from 15 to 26 May 2000, and
at United Nations Headquarters in New York from 5 June 2000 to 4 June 2001.

37.

ARTICLE 37

ENTRY INTO FORCE

1.

2.

This Protocol shall enter into force on the ninetieth day after the date of deposit
of the fiftieth instrument of ratification, acceptance, approval or accession by
States or regional economic integration organizations that are Parties to the
Convention.

This Protocol shall enter into force for a State or regional economic integration
organization that ratifies, accepts or approves this Protocol or accedes thereto

25

after its entry into force pursuant to paragraph 1 above, on the ninetieth day
after the date on which that State or regional economic integration organization
deposits its instrument of ratification, acceptance, approval or accession, or on
the date on which the Convention enters into force for that State or regional
economic integration organization, whichever shall be the later.

3.

For the purposes of paragraphs 1 and 2 above, any instrument deposited by a
regional economic integration organization shall not be counted as additional to
those deposited by member States of such organization

38.

ARTICLE 38

RESERVATIONS

No reservations may be made to this Protocol.

39.

ARTICLE 39

WITHDRAWAL

1.

2.

At any time after two years from the date on which this Protocol has entered
into force for a Party, that Party may withdraw from the Protocol by giving
written notification to the Depositary.

Any such withdrawal shall take place upon expiry of one year after the date of
its receipt by the Depositary, or on such later date as may be specified in the
notification of the withdrawal.

40.

ARTICLE 40

AUTHENTIC TEXTS

The original of this Protocol, of which the Arabic, Chinese, English, French, Russian
and Spanish texts are equally authentic, shall be deposited with the Secretary-
General of the United Nations.

IN WITNESS WHEREOF the undersigned, being duly authorized to that effect, have signed
this Protocol.

DONE at Montreal on this twenty-ninth day of January, two thousand.

26

Annex I

INFORMATION REQUIRED IN NOTIFICATIONS UNDER ARTICLES 8, 10
AND 13

Name, address and contact details of the exporter.

Name, address and contact details of the importer.

Name and identity of the living modified organism, as well as the domestic
classification, if any, of the biosafety level of the living modified organism in the
State of export.

Intended date or dates of the transboundary movement, if known.

Taxonomic status, common name, point of collection or acquisition, and
characteristics of recipient organism or parental organisms related to biosafety.

Centres of origin and centres of genetic diversity, if known, of the recipient organism
and/or the parental organisms and a description of the habitats where the organisms
may persist or proliferate.

Taxonomic status, common name, point of collection or acquisition, and
characteristics of the donor organism or organisms related to biosafety.

Description of the nucleic acid or the modification introduced, the technique used,
and the resulting characteristics of the living modified organism.

Intended use of the living modified organism or products thereof, namely, processed
materials that are of living modified organism origin, containing detectable novel
combinations of replicable genetic material obtained through the use of modern
biotechnology.

Quantity or volume of the living modified organism to be transferred.

A previous and existing risk assessment report consistent with Annex III .

Suggested methods for the safe handling, storage, transport and use,
including
packaging, labelling, documentation, disposal and contingency procedures, where
appropriate.

(a)

(b)

(c)

(d)

(e)

(f)

(g)

(h)

(i)

(j)

(k)

(l)

(m)

Regulatory status of the living modified organism within the State of export (for
example, whether it is prohibited in the State of export, whether there are other
restrictions, or whether it has been approved for general release) and, if the living
modified organism is banned in the State of export, the reason or reasons for the ban.

(n)

Result and purpose of any notification by the exporter to other States regarding the
living modified organism to be transferred.

(o)

A declaration that the above-mentioned information is factually correct.

27

Annex II

INFORMATION REQUIRED CONCERNING LIVING MODIFIED ORGANISMS
INTENDED FOR DIRECT USE AS FOOD OR FEED, OR FOR PROCESSING
UNDER ARTICLE 11

(a)

(b)

(c)

(d)

(e)

(f)

(g)

(h)

(i)

(j)

(k)

The name and contact details of the applicant for a decision for domestic use.

The name and contact details of the authority responsible for the decision.

Name and identity of the living modified organism.

Description of
characteristics of the living modified organism.

the gene modification,

the technique used, and the resulting

Any unique identification of the living modified organism.

Taxonomic status, common name, point of collection or acquisition, and
characteristics of recipient organism or parental organisms related to biosafety.

Centres of origin and centres of genetic diversity, if known, of the recipient organism
and /or the parental organisms and a description of the habitats where the organisms
may persist or proliferate.

Taxonomic status, common name, point of collection or acquisition, and
characteristics of the donor organism or organisms related to biosafety.

Approved uses of the living modified organism.

A risk assessment report consistent with Annex III.

including
Suggested methods for the safe handling, storage, transport and use,
packaging, labelling, documentation, disposal and contingency procedures, where
appropriate.

28

Annex III

RISK ASSESSMENT UNDER ARTICLE 15

Objective

1.

The objective of risk assessment, under this Protocol, is to identify and evaluate the
potential adverse effects of living modified organisms on the conservation and
sustainable use of biological diversity in the likely potential receiving environment,
taking also into account risks to human health.

Use of risk assessment

2.

Risk assessment
decisions regarding living modified organisms.

is, inter alia, used by competent authorities to make informed

General principles

3.

4.

5.

6.

Risk assessment should be carried out in a scientifically sound and transparent
manner, and can take into account expert advice of, and guidelines developed by,
relevant international organizations.

Lack of scientific knowledge or scientific consensus should not necessarily be
interpreted as indicating a particular level of risk, an absence of risk, or an acceptable
risk.

Risks associated with living modified organisms or products thereof, namely,
processed materials that are of living modified organism origin, containing detectable
novel combinations of replicable genetic material obtained through the use of
modern biotechnology, should be considered in the context of the risks posed by the
non-modified recipients or parental organisms in the likely potential receiving
environment.

Risk assessment should be carried out on a case-by-case basis. The required
information may vary in nature and level of detail from case to case, depending on
the living modified organism concerned, its intended use and the likely potential
receiving environment.

Methodology

7.

The process of risk assessment may on the one hand give rise to a need for further
information about specific subjects, which may be identified and requested during
the assessment process, while on the other hand information on other subjects may
not be relevant in some instances.

8.

To fulfil its objective, risk assessment entails, as appropriate, the following steps:

(a) An identification of any novel genotypic and phenotypic characteristics
associated with the living modified organism that may have adverse effects on
biological diversity in the likely potential receiving environment, taking also
into account risks to human health;

29

(b) An evaluation of the likelihood of these adverse effects being realized, taking
into account the level and kind of exposure of the likely potential receiving
environment to the living modified organism;

(c) An evaluation of the consequences should these adverse effects be realized;

(d) An estimation of the overall risk posed by the living modified organism based
on the evaluation of the likelihood and consequences of the identified adverse
effects being realized;

(e) A recommendation as to whether or not the risks are acceptable or manageable,
including, where necessary, identification of strategies to manage these risks;
and

(f) Where there is uncertainty regarding the level of risk, it may be addressed by
requesting further
information on the specific issues of concern or by
implementing appropriate risk management strategies and/or monitoring the
living modified organism in the receiving environment.

Points to consider

9.

Depending on the case, risk assessment takes into account the relevant technical and
scientific details regarding the characteristics of the following subjects:

(a) Recipient organism or parental organisms. The biological characteristics of the
recipient organism or parental organisms, including information on taxonomic
status, common name, origin, centres of origin and centres of genetic diversity,
if known, and a description of the habitat where the organisms may persist or
proliferate;

(b) Donor organism or organisms. Taxonomic status and common name, source,

and the relevant biological characteristics of the donor organisms;

(c) Vector. Characteristics of the vector, including its identity, if any, and its

source or origin, and its host range;

(d)

(e)

Insert or inserts and/or characteristics of modification. Genetic characteristics
of the inserted nucleic acid and the function it specifies, and/or characteristics
of the modification introduced;

Living modified organism. Identity of the living modified organism, and the
differences between the biological characteristics of the living modified
organism and those of the recipient organism or parental organisms;

(f) Detection and identification of the living modified organism. Suggested
detection and identification methods and their specificity, sensitivity and
reliability;

(g)

Information relating to the intended use. Information relating to the intended
use of the living modified organism, including new or changed use compared
to the recipient organism or parental organisms; and

30

(h) Receiving environment. Information on the location, geographical, climatic
information on biological

and ecological characteristics,
diversity and centres of origin of the likely potential receiving environment.

including relevant

31